Diabetes MellitusNo acronymNCT01259206
Plantar Faciitis and Diabetes Mellitus
An observational study of Diabetes Mellitus, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
Obesity is a risk factor for calcaneal spur (CS) formation which is supposed to originate from chronic plantar fasciitis. Diabetes mellitus may contribute to the risk of CS by decreased ability of tissue repair and increased reactive ossification. Read more about this study
- Who is it for?
- Ages 49 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2009to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 93 paitents and 42 control group
Who may be able to join
- Clinical diagnosis of Diabetes mellitus
- Must be obese
Who cannot join
- Previous radiotherapy to the foot,
- previous trauma to the foot (fracture, rupture of tendon),
- rheumatic or vascular diseases,
- malign diseases,
- lymphatic edema.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane School of Medicine Etlik
Ankara, 06600
About this study
Official title: Increased Calcaneal Spur Incidence in Patients With Obesity and Type 2 Diabetes Mellitus
Obesity is a risk factor for calcaneal spur (CS) formation which is supposed to originate from chronic plantar fasciitis. Diabetes mellitus may contribute to the risk of CS by decreased ability of tissue repair and increased reactive ossification. Thus, the investigators aimed to determine CS incidence in asymptomatic obese subjects with and without type 2 diabetes mellitus (T2DM).
Read the detailed description
OBJECTIVE-Obesity is a risk factor for calcaneal spur (CS) formation which is supposed to originate from chronic plantar fasciitis. Diabetes mellitus may contribute to the risk of CS by decreased ability of tissue repair and increased reactive ossification. Thus, the investigators aimed to determine CS incidence in asymptomatic obese subjects with and without type 2 diabetes mellitus (T2DM).
RESEARCH DESIGN AND METHODS-Ninety-three obese patients with T2DM and forty-two obese subjects without any metabolic disturbances as control were evaluated with lateral calcaneal x-ray in blinded fashion by a radiologist. All participants were informed and written consents have been obtained. Control cases were subjected to 75g glucose challenge test and glucose intolerant subjects were excluded.
RESULTS-T2DM and control groups were statistically similar in mean age (59±10.5 vs. 55±8 yrs, P=0.196, respectively) and mean body mass index (BMI)(35.1±4.3 vs. 33.1±3.3 kg/m2, P=0.073, respectively). Existence of calcaneal spur was 72% in 93 patients (77%) in T2DM group and 24 in 42 (57%) in control group. Groups were significantly different according to existence of CS (P=0.023). Mean age and mean BMI were significantly higher in diabetic patients with calcaneal spur than diabetic patients without calcaneal spur (p=0.001 and p=0.015, respectively). There was positive correlation between existence of calcaneal spur and peripheral neuropathy (p=0,043) in diabetics but no significant relation between existence of CS and glycolysed hemoglobin levels or diabetes duration (all P>0.05).
CONCLUSIONS-Clinicians should pay attention the increased incidence of CS in patients with T2DM to avoid foot complications.
- Conditions
- Diabetes Mellitus
- Keywords
- Calcaneal Spur, Diabetic Obese Patients
- Medical subject headings
- Diabetes Mellitus, Heel Spur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| diabetic patients | Not described | |
| diabetic patients and healty controls | there are two groups in this study. One group is obese type 2 diabetic patiens and other group is healty controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased Calcaneal Spur Incidence in Patients With Obesity and Type 2 Diabetes Mellitus
Calcaneal spur incidence is increased in patients with diabetes mellitus.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Aydoğan Aydoğdu, Principal investigator, No organizational affiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259206
- Sponsor's protocol ID
- 11.10.2008/127
- Acronym
- No acronym
- Status last verified
- Oct 2008
- First submitted
- 13 Dec 2010
- Last updated
- 21 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Calcaneal Spur Incidence in Patients With Obesity and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01259206
- Acronym / sponsor ID
- No acronym / 11.10.2008/127
- Conditions
- Diabetes Mellitus
- Keywords
- Calcaneal Spur, Diabetic Obese Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- Feb 2009
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is a risk factor for calcaneal spur (CS) formation which is supposed to originate from chronic plantar fasciitis. Diabetes mellitus may contribute to the risk of CS by decreased ability of tissue repair and increased reactive ossification. Thus, the investigators aimed to determine CS incidence in asymptomatic obese subjects with and without type 2 diabetes mellitus (T2DM).
Detailed description
OBJECTIVE-Obesity is a risk factor for calcaneal spur (CS) formation which is supposed to originate from chronic plantar fasciitis. Diabetes mellitus may contribute to the risk of CS by decreased ability of tissue repair and increased reactive ossification. Thus, the investigators aimed to determine CS incidence in asymptomatic obese subjects with and without type 2 diabetes mellitus (T2DM).
RESEARCH DESIGN AND METHODS-Ninety-three obese patients with T2DM and forty-two obese subjects without any metabolic disturbances as control were evaluated with lateral calcaneal x-ray in blinded fashion by a radiologist. All participants were informed and written consents have been obtained. Control cases were subjected to 75g glucose challenge test and glucose intolerant subjects were excluded.
RESULTS-T2DM and control groups were statistically similar in mean age (59±10.5 vs. 55±8 yrs, P=0.196, respectively) and mean body mass index (BMI)(35.1±4.3 vs. 33.1±3.3 kg/m2, P=0.073, respectively). Existence of calcaneal spur was 72% in 93 patients (77%) in T2DM group and 24 in 42 (57%) in control group. Groups were significantly different according to existence of CS (P=0.023). Mean age and mean BMI were significantly higher in diabetic patients with calcaneal spur than diabetic patients without calcaneal spur (p=0.001 and p=0.015, respectively). There was positive correlation between existence of calcaneal spur and peripheral neuropathy (p=0,043) in diabetics but no significant relation between existence of CS and glycolysed hemoglobin levels or diabetes duration (all P>0.05).
CONCLUSIONS-Clinicians should pay attention the increased incidence of CS in patients with T2DM to avoid foot complications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetic patients | – | – |
| diabetic patients and healty controls | – | –there are two groups in this study. One group is obese type 2 diabetic patiens and other group is healty controls. |
Who may qualify
- Ages
- 49 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 93 paitents and 42 control group
Key inclusion criteria (2 listed)
- Clinical diagnosis of Diabetes mellitus
- Must be obese
Key exclusion criteria (5 listed)
- Previous radiotherapy to the foot,
- previous trauma to the foot (fracture, rupture of tendon),
- rheumatic or vascular diseases,
- malign diseases,
- lymphatic edema.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Increased Calcaneal Spur Incidence in Patients With Obesity and Type 2 Diabetes Mellitus
Time frame: 3 months
Calcaneal spur incidence is increased in patients with diabetes mellitus.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aydoğan Aydoğdu principal investigator
No organizational affiliation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased Calcaneal Spur Incidence in Patients With Obesity and Type 2 Diabetes Mellitus (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2011.